HealthyNCT04979702
mHealth Biometrics for Sedentary People (MotivateLJMU)
A study testing mHealth technology assisted exercise counselling in people with Healthy, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- mHealth technology assisted exercise counselling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2020to 1 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female
- Aged 18-75
- No known cardiovascular or metabolic disorder (e.g. heart failure, diabetes, previous myocardial infarction etc.)
- Able to exercise safely as deemed by completion of the PAR-Q+.
- Not currently meeting the recommended exercise guidelines (150 minutes moderate or 75 minutes of vigorous intensity physical activity per week), as assessed during screening questions related to the participants previous activity levels.
Who cannot join
- Aged <18 or >75
- Pregnancy or planning to become pregnant in the next 3 months
- <6 months postpartum or stopped breastfeeding <1 month before recruitment
- Not owning a smartphone with a data plan or access to WiFi
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence
The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
Read the detailed description
Participants will be recruited from Liverpool John Moores University, and other local office-based businesses. Participants will be randomised to either online exercise resources only (n=50) or exercise counselling + mHealth (n=50).This is a pilot parallel group, randomised controlled trial whereby consenting participants will complete baseline testing (T1) before starting a 12-week exercise intervention supported by online resources only (online resources intervention) or online resources and a programme of exercise counselling enhanced with mobile health (mHealth) technology (mHealth intervention). Participants will repeat baseline assessments (i) 6-weeks into the intervention (T2) and, (ii) immediately post-intervention (T3). Testing at baseline and following the 12-week intervention will include changes in physical activity, blood pressure, body composition and glycaemia control (n=20).
Both groups will have access to online resources throughout the 12-week programme. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 4 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates.
- Conditions
- Healthy
- Being tested
- Active Control, mHealth technology assisted exercise counselling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active ControlBehavioural
Participants will complete a 3-month exercise and physical activity intervention supported by online recourses
mHealth technology assisted exercise counsellingBehavioural
Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology
| Study group | Role | What they receive |
|---|---|---|
| Active Control | Active comparator | Patients will have access to our online exercise resources throughout the 12-week intervention. Receives: Behavioral: Active Control |
| Experimental: mHealth technology assisted exercise counselling (mHealth) | Experimental | Participants will complete a 12 week mHealth technology assisted exercise counselling intervention. Participants will co-develop a 3-month structured exercise and PA programme, with support from an exercise specialist. All participants will have 4 exercise consultations with their exercise specialist. The intervention will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist. The 3 elements will be synced, allowing data to be transferred between platforms. Receives: Behavioral: mHealth technology assisted exercise counselling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device derived adherence to structured exercise
Number of exercise sessions per week
Measured: Through study completion, an average 12 weeks
Device derived duration to structured exercise
minutes of exercise completed per session
Measured: Through study completion, an average 12 weeks
Device derived intensity of structured exercise
intensity of exercise sessions performed (% of HR max)
Measured: Through study completion, an average 12 weeks
Change in Device derived physical activity (GENEActiv)
minutes of Moderate and Vigorous physical activity
Measured: Baseline, Mid intervention (Week 6-7), the final 2 weeks of intervention period (weeks 10-12).
Change in Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
Measured: Baseline, 4, 6, 8 12 weeks
Secondary outcomes (12)
Height
Height (m)
Measured: Baseline, 6-weeks and immediately following intervention (12 weeks)
Weight
Weight (kg)
Measured: Baseline, 6-weeks and immediately following intervention (12 weeks)
Waist Circumference
Waist Circumference (cm)
Measured: Baseline, 6-weeks and immediately following intervention (12 weeks)
Concentration of Hba1c
Hba1c
Measured: Baseline and immediately following intervention (12 weeks)
Blood Lipid concentrations
Total cholesterol, HDL/LDL, Triglycerides
Measured: Baseline and immediately following intervention (12 weeks)
Glycaemic control
Flash glucose monitoring
Measured: Baseline and immediately following intervention (12 weeks)
Patient qualitative survey on intervention acceptability
Study specific questionnaire (qualitative data)
Measured: Immediately following intervention (12 weeks)
Patient qualitative survey on testing acceptability
Study specific questionnaire (qualitative data)
Measured: 7 Days following baseline testing
Exercise motivation
Behavioural regulation in exercise questionnaire-2 (BREQ-2). Max score 76, min score 0, high score is better
Measured: Baseline, Mid (week 6) and post (week 12)
12-Item Short Form Survey
SF-12 Questionnaire (max 44 min 8, high score mean better outcome)
Measured: Baseline, Mid (week 6) and post (week 12)
Patient Interview to access intervention acceptability
Patient interview
Measured: Within 2 weeks of the end of the intervention
Patient Interview to access testing acceptability
Patient interview
Measured: Within 2 weeks of the baseline testing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start1 Aug 2020
- Primary completion1 Apr 2022
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Cocks, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04979702
- Sponsor's protocol ID
- MotivateLJMU
- Status last verified
- Aug 2022
- First submitted
- 16 Jul 2021
- Last updated
- 23 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Health Biometrics to Enhance Exercise and Physical Activity Adherence
- ClinicalTrials.gov ID
- NCT04979702
- Acronym / sponsor ID
- MotivateLJMU
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to undertake a feasibility randomised controlled trial (RCT) to investigate whether mHealth technology, allowing biometric informed feedback and coaching on exercise and PA, can be effective in previously sedentary individuals. The overall objective is to have an evidence-based exercise and PA intervention ready to evaluate in a future RCT.
Detailed description
Participants will be recruited from Liverpool John Moores University, and other local office-based businesses. Participants will be randomised to either online exercise resources only (n=50) or exercise counselling + mHealth (n=50).This is a pilot parallel group, randomised controlled trial whereby consenting participants will complete baseline testing (T1) before starting a 12-week exercise intervention supported by online resources only (online resources intervention) or online resources and a programme of exercise counselling enhanced with mobile health (mHealth) technology (mHealth intervention). Participants will repeat baseline assessments (i) 6-weeks into the intervention (T2) and, (ii) immediately post-intervention (T3). Testing at baseline and following the 12-week intervention will include changes in physical activity, blood pressure, body composition and glycaemia control (n=20).
Both groups will have access to online resources throughout the 12-week programme. The intervention group will be provided with exercise counselling and to support this they will also be provide with a wristwatch that can monitor everyday activity and their heart rate, a smartphone app and access to a website. The intervention group will also participate in 4 consultations with an exercise specialist to plan their exercise programme and be updated on their progress towards physical activity targets. Weekly text message updates will also provide feedback to the intervention group with participants able to respond to these updates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active Control | Active comparator | Behavioral: Active ControlPatients will have access to our online exercise resources throughout the 12-week intervention. |
| Experimental: mHealth technology assisted exercise counselling (mHealth) | Experimental | Behavioral: mHealth technology assisted exercise counsellingParticipants will complete a 12 week mHealth technology assisted exercise counselling intervention. Participants will co-develop a 3-month structured exercise and PA programme, with support from an exercise specialist. All participants will have 4 exercise consultations with their exercise specialist. The intervention will be supported by 3 mHealth elements; 1) a wrist worn fitness watch, 2) a smartphone app for patients, and 3) a coaching website for the exercise specialist. The 3 elements will be synced, allowing data to be transferred between platforms. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female
- Aged 18-75
- No known cardiovascular or metabolic disorder (e.g. heart failure, diabetes, previous myocardial infarction etc.)
- Able to exercise safely as deemed by completion of the PAR-Q+.
- Not currently meeting the recommended exercise guidelines (150 minutes moderate or 75 minutes of vigorous intensity physical activity per week), as assessed during screening questions related to the participants previous activity levels.
Key exclusion criteria (4 listed)
- Aged <18 or >75
- Pregnancy or planning to become pregnant in the next 3 months
- <6 months postpartum or stopped breastfeeding <1 month before recruitment
- Not owning a smartphone with a data plan or access to WiFi
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active ControlParticipants will complete a 3-month exercise and physical activity intervention supported by online recourses | Behavioural | Active Control |
| mHealth technology assisted exercise counsellingParticipants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology | Behavioural | Experimental: mHealth technology assisted exercise counselling (mHealth) |
Primary outcome
Device derived adherence to structured exercise
Time frame: Through study completion, an average 12 weeks
Number of exercise sessions per week
Device derived duration to structured exercise
Time frame: Through study completion, an average 12 weeks
minutes of exercise completed per session
Device derived intensity of structured exercise
Time frame: Through study completion, an average 12 weeks
intensity of exercise sessions performed (% of HR max)
Change in Device derived physical activity (GENEActiv)
Time frame: Baseline, Mid intervention (Week 6-7), the final 2 weeks of intervention period (weeks 10-12).
minutes of Moderate and Vigorous physical activity
Change in Survey reported exercise behaviour (Godin Leisure Time Exercise Questionnaire (GLTEQ))
Time frame: Baseline, 4, 6, 8 12 weeks
Bouts of mild, moderate and strenuous exercise lasting ≥30 minutes
12 secondary outcomes
Height
Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Weight
Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Waist Circumference
Time frame: Baseline, 6-weeks and immediately following intervention (12 weeks)
Concentration of Hba1c
Time frame: Baseline and immediately following intervention (12 weeks)
Blood Lipid concentrations
Time frame: Baseline and immediately following intervention (12 weeks)
Glycaemic control
Time frame: Baseline and immediately following intervention (12 weeks)
Patient qualitative survey on intervention acceptability
Time frame: Immediately following intervention (12 weeks)
Patient qualitative survey on testing acceptability
Time frame: 7 Days following baseline testing
Exercise motivation
Time frame: Baseline, Mid (week 6) and post (week 12)
12-Item Short Form Survey
Time frame: Baseline, Mid (week 6) and post (week 12)
Patient Interview to access intervention acceptability
Time frame: Within 2 weeks of the end of the intervention
Patient Interview to access testing acceptability
Time frame: Within 2 weeks of the baseline testing
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2022.
- Individual participant dataSharing planned: No. No plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth technology assisted exercise counselling in people with Healthy, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device derived adherence to structured exercise (time frame: Through study completion, an average 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2022.